Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation

Arthrex

Status: Unknown

Conditions: Lateral Ankle Instability

Treatments: Device: Modified Brostrum procedure with Internal Brace Augmentation; Device: Modified Brostrum procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04770818

928

Details and patient eligibility

About

Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature. Although success rates are high, the incidence of recurrent instability is well documented. In addition, with standard rehabilitation protocols, the timeline to return to sport and functional activities may be prolonged. The InternalBrace Ligament Augmentation Repair is a safe and reproducible technique using FiberTape® and BioComposite SwiveLock® as an augmentation to a Brostrom procedure. The InternalBrace Ligament Augmentation repair consists of a FiberTape bridge between two Knotless Swivelock anchors providing a protective reinforcement and allows the surgeon to repair lateral or medial ankle instability and the pain associated with it. This type of repair can be utilized in acute and chronic ankle sprains.

Full description

It is hypothesized that use of InternalBrace Ligament Augmentation in addition to standard anatomic modified Brostrum repair allows for earlier return to pre-injury level compared to a standard Brostrum procedure. It is also secondarily hypothesized that intermediate and long term incidence of recurrent instability will be lower with use of internal brace augmentation of standard modified Brostrum lateral ankle ligament reconstruction.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Subjects that consent to the study
• Ages 18 and older
• Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
• Able to understand, complete and sign/date the Informed Consent Form (ICF)

Exclusion criteria

• Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
• Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
• Systemic laxity
• Bony correction (i.e. calcaneal osteotomy)
• Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
• Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
• Revision surgery
• Inadequate tissue for standard Brostrum reconstruction
• Neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Modified Brostrum procedure

Active Comparator group

Description:

Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL (anterior talo-fibular ligament), CFL (calcanealfibular ligament), lateral ankle capsule and extensor retinaculum.

Treatment:

Device: Modified Brostrum procedure

Modified Brostrum procedure with InternalBrace ligament augmentation

Active Comparator group

Description:

Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL, CFL, lateral ankle capsule and extensor retinaculum with InternalBrace fixation using a 4.75mm BioComposite SwiveLock.

Treatment:

Device: Modified Brostrum procedure with Internal Brace Augmentation